N/A
N=26
Alvimopan and Ileus in PSF
Ileus · Spinal Fusion
Bottom Line
View on ClinicalTrials.gov: NCT02218190 ↗Enrolled (actual)
26
Serious AEs
19.2%
Results posted
May 2019
Primary outcome: Primary: Recovery of Bowel Function — 43.2; 34.0 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alvimopan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery of Bowel Function |
43.2; 34.0 | — |
| PRIMARY Length of Hospital Stay |
122.5; 117.2 | — |
| SECONDARY Complications and Adverse Event |
0; 0 | — |
Summary
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
Eligibility Criteria
Inclusion Criteria
- adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis
Exclusion Criteria
- pregnant women
- ischemic heart disease
- chronic liver or renal disease
- prior bowel resection
- presence of colostomy or ileostomy
- gastroparesis
- complete bowel obstruction
- inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Data sourced from ClinicalTrials.gov (NCT02218190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.